INTIBIA Pivotal Study

Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).

Inclusion Criteria: * Women or men 22-80 years of age * Symptoms of overactive bladder with urgency urinary incontinence (UUI) demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, and at least one leaking episode each 24-hour period * Greater than or equal to 6-month history of UUI diagnosis * Failure of conservative or behavioral therapy (e.g., bladder diet, timed voiding, bladder training, bladder control strategies, pelvic floor muscle training, fluid management) * Willing to abstain from OAB medications for the duration of the study * Willing to maintain a stable dose of all other medications that affect bladder function (e.g., tricyclic antidepressants) for at least four (4) weeks prior to beginning the baseline voiding diary and baseline questionnaires * Ambulatory and able to use the toilet independently and without difficulty * Willing and capable of providing informed consent * Willing and able to complete all procedures and follow-up visits indicated in the protocol Exclusion Criteria: * Diagnosis of stress urinary incontinence or mixed urinary incontinence, as confirmed by cough stress test and with a response of Yes to Q3 on the UDI-6 questionnaire * Current symptomatic urinary tract infection (UTI), urethritis, or more than three (3) UTIs in past year * Have post-void residual urine volume \>30% of total voided volume * Inadequate skin integrity, any evidence of an infection, or lower leg edema limiting placement of device per physician discretion * Evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject * Prior treatment of urinary symptoms with nerve stimulation (e.g., percutaneous tibial nerve stimulation \[PTNS\] or sacral nerve stimulation \[SNS\]) * History of chronic pain (e.g., chronic pelvic pain, fibromyalgia, Lyme disease, chronic back pain) * An active implantable electronic device regardless of whether stimulation is ON or OFF * Treatment of urinary symptoms with botulinum toxin therapy within six (6) months * Any neurological condition that could interfere with normal bladder or tibial nerve function, including debilitating stroke, epilepsy, multiple sclerosis, Parkinson's disease, peripheral neuropathy, fibromyalgia, or spinal cord injury (e.g., paraplegia) * Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture) * Other urinary tract dysfunction (e.g., abnormal upper urinary tract function, vesicoureteral reflux, bladder stone or tumor, urinary fistula) * End stage renal failure, GFR \< 35, or dialysis * History of pelvic cancer requiring radiation or chemotherapy treatment within the past two years * Pelvic organ prolapse at or beyond the hymenal ring * Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines prior to INTIBIA implant date * Diabetes with peripheral nerve compromise or uncontrolled diabetes * Pregnant as confirmed by urine or serum pregnancy test, plans to become pregnant over the study period, is less than one-year post-partum, is breast-feeding * Current active or a chronic systemic infection * Condition requiring magnetic resonance imaging (MRI) of lower leg * Condition requiring diathermy * Allergy to polyethylene terephthalate, silicone rubber, platinum, iridium, or polyurethane * Allergy to local anesthetic or adhesives * Deemed unsuitable for enrollment by the investigator based on history or physical examination (e.g., bleeding disorders, current anticoagulant medications) * Enrolled in another investigational or interventional device or drug trial over the study period